FDA Adverse Event
Injury
Summary report: N
COMPONENT MONITORING SYSTEM
MDR report key: 4036334
·
Received August 18, 2014
Report
- Report Number
- 9610816-2014-00222
- Event Type
- Injury
- Date Received
- August 18, 2014
- Date of Event
- August 7, 2017
- Report Date
- August 11, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DRT
- PMA / PMN Number
- K002758
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED TO PHILIPS HEALTHCARE THAT CUSTOMER WAS GETTING AN ISSUE WITH A MISSING AUDIBLE ALARM. VISUAL ALARMS WERE WORKING BUT THERE WAS NO SOUND. THE PATIENT WAS ALSO ATTACHED TO A CENTRAL STATION AND PER THE CUSTOMER THERE WAS NO SOUND AT THE CENTRAL STATION TOO. THE DOCTOR REPORTED THAT THE PATIENT HAD A "BREATHING ISSUE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 495179 | COMPONENT MONITORING SYSTEM | MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) | DRT | PHILIPS MEDICAL SYSTEMS | M1166A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |